FDA Device recall Z-0590-2018
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
- FDA Device
- Class III
- ongoing
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class III recall of Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 by C R Bard, citing label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0590-2018 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2017-06-02 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | n/a |
Product
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Reason
Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
Identifiers
| code_info | Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0590-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.